BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4864127 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-68010
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS MONITORED FOR TWENTY FOUR HOURS WITH MULTIPLE BASAL RATES, NO BLANK DISPLAY, DISPLAY ANOMALY OR DAMAGE INSIDE PUMP NOTED. HOWEVER, THE BATTERY CAP CONTACT WAS CORRODED. ALL OF THE OPERATING CURRENTS WERE NORMAL. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR INSULIN PUMP HAD A BLANK DISPLAY SCREEN. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 249 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THERE WERE NO SIGNIFICANT EVENTS THAT COULD HAVE LED TO THE ISSUE. THE CUSTOMER WAS INFORMED THAT (B)(6) AAA ALKALINE BATTERIES ARE MOST EFFECTIVE. THE CUSTOMER STATES THAT THE BATTERY CAP HAS GREY MATTER AROUND IT. THE CUSTOMER WAS ASSISTED WITH THE ISSUE BUT THE BLACK DISPLAY WAS NOT RESOLVED. THE CUSTOMER WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405555 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR